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Terminated

Foundation Knee System, Patella Trial, 26 mm, part number 802-01-019, Lot number 53944551

FDA Recall Z-1255-2010 · Posted 2010-04-07

Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeJWH
Date Initiated2010-02-22
Date Terminated2010-07-22
Product Quantity2 units

Reason for Recall

One lot of product was incorrectly manufactured. Pegs are larger than specification.

Firm Action

Firm notified consignees by e-mail on 2/22/2010.

Root Cause

Process control

Distribution Pattern

United States (FL and ID).

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K932246FOUNDATION METAL-BACKED PATELLAEncore Orthopedics, Inc. · 1994-07-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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