Device recall: BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number: 72200775 Biodegradable suture anchor
Class II FDA enforcement event 66037. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
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. Endoscopy Division started this device recall on 6 Aug 2013. The firm address in the FDA record is in Andover, MA. FDA put the recall in Class II. FDA event 66037 has 26 product records. The first FDA enforcement report date is 25 Sep 2013. The record gives the status Terminated, with the termination date 20 Apr 2016.
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 . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway,…
Recalling firm
Smith & Nephew, Inc. Endoscopy Division, Andover, MA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
26 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2215-2013 | BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number: 72200775 Biodegradable suture anchor | 43385 US | Class II | Terminated | 25 Sep 2013 |
| Z-2216-2013 | BIORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture; Part Number: 72200774 Biodegradable suture anchor | 24574 US | Class II | Terminated | 25 Sep 2013 |
| Z-2217-2013 | BIORAPTOR 2.9 mm Suture Anchor with DURABRAID" Suture; Part Number: 72200783 Biodegradable suture anchor | 1735 US | Class II | Terminated | 25 Sep 2013 |
| Z-2218-2013 | BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture; Part Number: 72200690 Biodegradable suture anchor | 725 US | Class II | Terminated | 25 Sep 2013 |
| Z-2219-2013 | BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biodegradable suture anchor | 240 US | Class II | Terminated | 25 Sep 2013 |
| Z-2220-2013 | OSTEORAPTOR 2.3 mm Suture Anchor with ULTRABRAID COBRAID Suture, Blue; Part Number: 72201993 Biodegradable suture anchor | 25733 | Class II | Terminated | 25 Sep 2013 |
| Z-2221-2013 | OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue ; Part Number: 72201995 Biodegradable suture anchor | 17696 US | Class II | Terminated | 25 Sep 2013 |
| Z-2222-2013 | OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White; Part Number: 72201991 Biodegradable suture anchor | 22879 US | Class II | Terminated | 25 Sep 2013 |
| Z-2223-2013 | OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black; Part Number: 72201992 Biodegradable suture anchor | 18919 | Class II | Terminated | 25 Sep 2013 |
| Z-2224-2013 | OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; Part Number: 72201994 Biodegradable suture anchor | 6373 US | Class II | Terminated | 25 Sep 2013 |
| Z-2225-2013 | OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Part Number: 72201996 Biodegradable suture anchor | 5873 US | Class II | Terminated | 25 Sep 2013 |
| Z-2226-2013 | OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Number: 72202165 Biodegradable suture anchor | 4452 US | Class II | Terminated | 25 Sep 2013 |
| Z-2227-2013 | OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number: 72203291 Biodegradable suture anchor | 4946 US | Class II | Terminated | 25 Sep 2013 |
| Z-2228-2013 | OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue; Part Number: 72203290 Biodegradable suture anchor | 10296 US | Class II | Terminated | 25 Sep 2013 |
| Z-2229-2013 | TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue; Part Number: 72202597 Biodegradable suture anchor | 8889 US | Class II | Terminated | 25 Sep 2013 |
| Z-2230-2013 | TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202624 Biodegradable suture anchor | 6985 US | Class II | Terminated | 25 Sep 2013 |
| Z-2231-2013 | TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202626 Biodegradable suture anchor | 3827 US | Class II | Terminated | 25 Sep 2013 |
| Z-2232-2013 | TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202631 Biodegradable suture anchor | 708 US | Class II | Terminated | 25 Sep 2013 |
| Z-2233-2013 | TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black: Part Number: 72202602 Biodegradable suture anchor | 7148 US | Class II | Terminated | 25 Sep 2013 |
| Z-2234-2013 | TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Number: 72202603 Biodegradable suture anchor | N/A | Class II | Terminated | 25 Sep 2013 |
| Z-2235-2013 | TWINFIX" Ultra PLLA/HA 6.5 mm with 2 ULTRABRAID" Suture, White / Black: Part Number: 72202608 Biodegradable suture anchor | 1308 US | Class II | Terminated | 25 Sep 2013 |
| Z-2236-2013 | TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture; Part Number: 72202610 Biodegradable suture anchor | 1643 | Class II | Terminated | 25 Sep 2013 |
| Z-2237-2013 | RAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles; Part Number: 72201805 Biodegradable suture anchor | 1965 US | Class II | Terminated | 25 Sep 2013 |
| Z-2238-2013 | TWINFIX" Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID") with Needles; Part Number: 72202612 Biodegradable suture anchor | 1571 US | Class II | Terminated | 25 Sep 2013 |
| Z-2239-2013 | TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202616 Biodegradable suture anchor | 2038 US | Class II | Terminated | 25 Sep 2013 |
| Z-2240-2013 | TWINFIX Ultra 6.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202620 Biodegradable suture anchor | 314 US | Class II | Terminated | 25 Sep 2013 |
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 2013
- 1,236
- Share of these events in Class II
- 90%
- Product records in this event
- 26Median of the firm: 5
- Events of the firm on the register
- 4
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 2 Jun 2014 | SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener, fixation, nondegradable, soft t | Device | Class II | 5 |
| 14 Jul 2012 | Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECUTTER Part Number: 72202213 Product Usage: T | Device | Class II | 2 |
| 3 Jul 2012 | Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures (blue, blue-COBRAID) with Needles Pr | Device | Class II | 4 |
Official channels
- FDA enforcement report Z-2215-2013The 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 66037. https://recallregister.com/fda/ii/66037/. Source: openFDA enforcement reports. Data through .
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:
Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway,…
- What quantity of product is in FDA event 66037?
- The event has 26 product records. The first record gives this quantity:
43385 US
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2013 have the same class?
- 90% of the 1,236 device events that started in 2013 are in Class II.