Data Foundry

Medical device recalls 2016

Product 25 consists of all product under product code: LPH and same… — Class II medical device recall Z-1123-2016

Terminated recall by Zimmer Manufacturing B.V., reported 2016-03-23, distributed nationwide. As a result of the insufficient sealer calibration data for product packaged in firm's Building II between Aug

Recall numberZ-1123-2016
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmZimmer Manufacturing B.V., Mercedita, PR, United States
Recall initiated2016-01-11
Classified2016-03-12
Reported by FDA2016-03-23
Terminated2017-04-13
DistributedNationwide (US)
Quantity2
Reason classessterility
Lot numbers62233575, 62255244
Model numbers234703104

Product

Product 25 consists of all product under product code: LPH and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL MEDIAL FEMORAL CON 234703208 DISTAL MEDIAL FEMORAL CON 234800504 DISTAL POSTERIOR/LATERAL 234800506 DISTAL POSTERIOR/LATERAL 234800508 DISTAL POSTERIOR/LATERAL 234800510 DISTAL POSTERIOR/LATERAL 234800604 DISTAL POSTERIOR/LATERAL 234800606 DISTAL POSTERIOR/LATERAL 234800608 DISTAL POSTERIOR/LATERAL 234800610 DISTAL POSTERIOR/LATERAL 234800614 DISTAL POSTERIOR/LATERAL For use in total hip arthroplasty

Reason for recall

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1123-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.