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PRELUDE PF
Biomet Orthopedics, LLC · Model 010001758 · UDI-DI 00880304564336
KRR
Prescription
1
510(k) clearances
249
Adverse events
9
Recalls
113
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-12-22 | MEDLINE INDUSTRIES, LP - Northfield | The recall is due to observed intra-operative screw failure. When pre-drilled with 1.3mm drill bit for 2.0mm screws and 1.6mm drill bit for 2.4mm we have observed screw failure due |
| 2022-12-22 | MEDLINE INDUSTRIES, LP - Northfield | The recall is due to observed intra-operative screw failure. When pre-drilled with 1.3mm drill bit for 2.0mm screws and 1.6mm drill bit for 2.4mm we have observed screw failure due |
| 2022-12-22 | MEDLINE INDUSTRIES, LP - Northfield | The recall is due to observed intra-operative screw failure. When pre-drilled with 1.3mm drill bit for 2.0mm screws and 1.6mm drill bit for 2.4mm we have observed screw failure due |
| 2017-11-29 | Zimmer Biomet, Inc. | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant aft |
| 2017-11-29 | Zimmer Biomet, Inc. | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant aft |
| 2016-03-09 | Biomet, Inc. | Inadequate design control. |
| 2016-01-11 | Zimmer Biomet, Inc. | LDPE bag containing the implant adheres to the highly polished implant surface. |
| 2014-07-30 | Zimmer, Inc. | Internal review found that five (5) PFJ implant forgings were identified as have forged laps during receiving inspection process for raw material. These five forgings were not segr |
| 2013-08-30 | Zimmer, Inc. | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.