Reported May 16, 2018 · Terminated
Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in…
Zimmer Biomet, Inc.
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: Zimmer Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989
Is this the product you have?
- Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.
- Lot codes and dates
- Lots(Updated 3/20/19)
292 of 292 codes
013040013050013060013070013080013090013100013120013130013140013150025720038090038100038110038120038130038160038170038200038210038220038230054050054070054080054090054110075970089200089210108270108280110830110840110860110870110900110910110920110930110940110950110980110990111000111010111020111030111070144270144280147300147350165500165510173190173210173220173230
- Expanded Lots
69 of 69 codes
538220593400331850538510593410379800538880593430691290538900615370054070538940615380110860662300615390110900699490615400110940699600615410111030991750615420173290379730615630218330379910662320218340538120662330331750538180662370331820538250662380331840538310699470331880538370699500379760538480699520379810538520699540379870538610699560379920538630699570444380
- Lots
- Amount recalled
- 13175
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
The recalling firm has confirmed that the Outer Plate component exhibits an excessive chamfer on the threading after deburring operations. This excessive chamfer results in non-conforming product where the threads of the outer plate component have limited to no engagement with the post component.
This product could cause temporary or reversible health problems — stop using it.
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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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