Food, drugs, devices › Stryker Howmedica Osteonics Corp.

Device recall: GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah

FDA enforcement event 65646 · Class II · initiated 21 May 2013 · status Terminated · terminated 14 Oct 2014

DeviceVoluntary: Firm initiated1 product recordMahwah, NJ

Stryker Howmedica Osteonics Corp. (Mahwah, NJ) initiated this device recall on 21 May 2013; FDA lists 1 product record under event 65646, classified Class II.

FDA defines Class II as 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. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.

Status: Terminated, terminated 14 Oct 2014. Initiation: voluntary: firm initiated. Stryker Howmedica Osteonics Corp. has 59 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Stryker Howmedica Osteonics Corp., Mahwah, NJ.

Reason for recall

"Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails."

Distribution

"US Distribution including the states of IL, KY and TN."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1846-2013	GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA A single use device intended for the temporary fixation, correction of stabilization of the right femur. The kit consists of intramedullary nail and set screw. The kit is used in…	5 units	Class II	Terminated	7 Aug 2013

Context

90%of 2013 device events are Class II1,236 events that year

1product record in this eventfirm median: 1

59events on this register for the firm

Other enforcement events for Stryker Howmedica Osteonics Corp.

Initiated	Product (first record)	Type	Class	Records
26 Apr 2017	Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131475(10)V07241 Produc	Device	Class II	1
2 Dec 2016	Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound (PIN 5901-1038, Revision A) is an instrument	Device	Class II	1
9 Nov 2016	GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-	Device	Class II	1
29 Aug 2016	LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed	Device	Class II	1
18 Aug 2016	Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp.	Device	Class II	1
1 Aug 2016	Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10) The Scorpio P	Device	Class II	1
1 Jul 2016	Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter fem	Device	Class II	1
30 Jun 2016	Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable internal fixat	Device	Class II	2
23 Jun 2016	Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC M546654148080S Prod	Device	Class II	1
23 Jun 2016	Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to complement or	Device	Class II	1

All 59 events for Stryker Howmedica Osteonics Corp.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is 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.

Where was the product distributed?

FDA's distribution pattern field reads: "US Distribution including the states of IL, KY and TN."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 14 Oct 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.