Device recall: TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309

Class II FDA enforcement event 86462. Recall start date: 9 Sep 2020. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Smith & Nephew, Inc. started this device recall on 9 Sep 2020. The firm address in the FDA record is in Andover, MA. FDA put the recall in Class II. FDA event 86462 has 40 product records. The first FDA enforcement report date is 28 Oct 2020. The record gives the status Ongoing.

FDA enforcement report The 40 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI,…

Recalling firm

Smith & Nephew, Inc., Andover, MA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

40 product records in the event.

FDA event 86462: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0136-2021	TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0137-2021	TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0138-2021	TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0139-2021	TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Number: 7210712	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0140-2021	TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number: 7210713	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0141-2021	TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA-Absorbable Suture anchors Product Number:72200777	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0142-2021	TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Number: 72200785	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0143-2021	ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493	N/A	Class II	Ongoing	28 Oct 2020
Z-0144-2021	ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0145-2021	ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0146-2021	BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0147-2021	RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0148-2021	OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0149-2021	OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0150-2021	OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0151-2021	OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0152-2021	OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995	N/A	Class II	Ongoing	28 Oct 2020
Z-0153-2021	OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number: 72201996	N/A	Class II	Ongoing	28 Oct 2020
Z-0154-2021	OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0155-2021	TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0156-2021	TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0157-2021	TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Number: 72202608	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0158-2021	TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 72202610	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0159-2021	TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202612	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0160-2021	TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202616	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0161-2021	TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0162-2021	TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202624	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0163-2021	TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202626	N/A	Class II	Ongoing	28 Oct 2020
Z-0164-2021	TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product Number: 72202631	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0165-2021	OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0166-2021	OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Number: 72203291	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0167-2021	HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203697	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0168-2021	HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number: 72203704	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0169-2021	HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0170-2021	HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0171-2021	HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number: 72203707	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0172-2021	HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product Number: 72203708	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0173-2021	HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203801	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0174-2021	MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204983	263,874 (total)	Class II	Ongoing	28 Oct 2020
Z-0175-2021	MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984	263,874 (total)	Class II	Ongoing	28 Oct 2020

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2020: 916
Share of these events in Class II: 93%
Product records in this event: 40Median of the firm: 1
Events of the firm on the register: 107

Other events of the firm

Other FDA enforcement events of Smith & Nephew, Inc.
Initiated	Product (first record)	Type	Class	Records
16 Mar 2026	TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816	Device	Class II	1
24 Nov 2025	BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.	Device	Class II	1
18 Mar 2025	META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690	Device	Class II	1
29 Oct 2024	BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.	Device	Class II	1
15 Oct 2024	Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femo	Device	Class II	1
2 Oct 2024	smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELL	Device	Class II	2
2 Oct 2024	smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur	Device	Class II	2
12 Aug 2024	ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Pro	Device	Class II	2
9 Jul 2024	DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener	Device	Class II	2
24 Apr 2024	smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71	Device	Class II	1

Smith & Nephew, Inc.: all 107 events

Official channels

FDA enforcement report Z-0136-2021The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 86462. https://recallregister.com/fda/ii/86462/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI,…
What quantity of product is in FDA event 86462?: The event has 40 product records. The first record gives this quantity: 263,874 (total)
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2020 have the same class?: 93% of the 916 device events that started in 2020 are in Class II.