FDA Medical Device Recalls (openFDA)
Biomet U.K., Ltd.: Oxford Partial Knee System Left Medial Tibial Trial Tray Size E Product Usage: Instruments for use with the Oxford Uni Partial Knee System
- Recall number
- Z-1161-2017
- Recalling firm
- Biomet U.K., Ltd.
- Product
- Oxford Partial Knee System Left Medial Tibial Trial Tray Size E Product Usage: Instruments for use with the Oxford Uni Partial Knee System
- Status
- Terminated
- Initiated
- 2016-01-05
- Posted
- not on file
- Terminated
- 2018-06-30
- Reason
- Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument.
- Root cause
- Nonconforming Material/Component
- Action
- Zimmer Biomet initiated a voluntary recall of the Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the ffected products by mailing letters via FedEx on 01/05/2017. Customers were instructed to Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in their inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form. a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form and Attachment 2 Certificate of Decontamination to Zimmer Biomet. a. Request a Return Authorization Number via email to rgarequest@zimmerbiomet.com or through FAST/SMS. Be sure to specify RECALL as the RGA type. b. For each return, send a copy of Attachment 1 and Attachment 3 to corporatequality.postmarket@zimmerbiomet.com. c. Include a hardcopy of Attachment 1 with your shipment for immediate processing. d. Include a hardcopy of Attachment 2 with returned instruments. Mark the outside of the returned boxes clearly with RECALL. 5. Using the Additional Accounts Form provided with the email notice sent to your facility, return contact information for any additional hospitals that may have received or used the affected product. If there are no additional users to notify, please indicate none or NA on the form and return. 6. Retain a copy of your recall acknowledgement and product return forms for your records in the event of a compliance audit of your facility. 7. If after reviewing the recall notice you have further questions or concerns please call the customer call center at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outs
- Quantity
- 72 units in total
- Distribution
- Worldwide Distribution in the states of LA, NC, AR, MT, MO, CA, NY, KS, TX, MA, KY, OK, SC, NJ and the countries of Foreign: THAILAND, JAPAN, NETHERLANDS
- Lot, serial or model codes
- Item: 32-420736, Lots: ZB160501, ZB160601
- 510(k) numbers
- not on file
- PMA numbers
- ["P010014"]
- Product code
- NRA
- Firm FEI
- 3002806535
- Firm city
- South Wales
- Firm state
- Bridgend
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28