Reported Mar 14, 2018 · Terminated

3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351.76S Reaming Rods are intended for guiding…

Synthes (USA) Products LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Synthes (USA) Products LLC · 1301 Goshen Pkwy · West Chester, PA · 19380-5986

3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile
Part Number351.76S Reaming Rods are intended for guiding of reamers during orthopedic surgery

Lot codes and dates: Distributed 25-Apr-2017 to 22-Jun-2017; Lot Number Manufacturing Date (M/D/YYYY)
Expiration Date (YYYY-MM-DD)
H306632
4/3/2017
2026-02-28
H311229
4/16/2017
2026-03-31
H311228
4/28/2017
2026-03-31
H311231
4/28/2017
2026-03-31
H319172
4/28/2017
2026-03-31
H319175
4/28/2017
2026-03-31
H318789
5/4/2017
2026-03-31
H319171
5/4/2017
2026-03-31
H327068
5/4/2017
2026-03-31
H311226
5/6/2017
2026-03-31
H311225
5/11/2017
2026-04-30
H311224
5/12/2017
2026-04-30
H327067
5/12/2017
2026-04-30
H327066
5/18/2017
2026-04-30
Amount recalled: 960

The agency filed one notice per product. You are reading one of them; the other 6 are below.

Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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58 in total.